The Aponos Medical Padlock Clip™ is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of gastrointestinal organs.

The Padlock Clip is indicated for clip placement within the Gastro-intestinal (GI) tract for the purpose of:

Endoscopic marking of lesions. .
Hemostasis for .
- Mucosal/Sub mucosal defects o
- o Bleeding Ulcers
- Arteries <2mm o
- Polyps <1.5cm diameter O
- Diverticula in the Colon o
Closure of GI tract luminal perforations < 20mm that can be treated . conservatively.

Device Description

The Padlock Clip™ ligation clip consists of a preloaded, radiopaque, single use, coin sized ligation clip made of superelastic shape memory alloy (Nitinol®) for tissue approximation device with opening sizes of 6 to 24mm on a flexible delivery system.

AI/ML Overview

Here's an analysis of the provided text regarding the Aponos Medical Padlock Clip™, focusing on acceptance criteria and supporting studies.

Based on the provided document (K120814), the details regarding acceptance criteria and a study to prove the device meets them are very limited. This document is a 510(k) summary and clearance letter, indicating it focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results and acceptance criteria in the way a PMA submission might.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Specific performance criteria (e.g., clip deployment success rate, hemostasis efficacy, closure success rate for perforations)	Not explicitly stated in this document. The document states: "Aponos Medical has conducted appropriate testing and has determined that the Padlock Clip ligation clip is acceptable for its intended use."
Functional tests (e.g., clip opening size integrity, delivery system flexibility and deployment)	"The results of animal and performance testing show no new issues of safety or effectiveness." (No specific results or acceptance criteria provided)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified in this document.
Data Provenance: The document mentions "animal and performance testing" but does not specify the country of origin or whether these were retrospective or prospective studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable/Not specified. The document does not describe the use of an expert panel to establish ground truth for a test set in the context of clinical performance evaluation. The testing mentioned appears to be more focused on technical performance and animal studies.

4. Adjudication Method for the Test Set

Not applicable/Not specified. There is no mention of a clinical test set requiring adjudication in this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is not mentioned. This type of study is typically for evaluating the performance of AI algorithms in interpreting medical images, and the Padlock Clip™ is a physical medical device, not an AI diagnostic tool.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

Not applicable. This question pertains to AI algorithms. The Padlock Clip™ is a physical device, so a "standalone" algorithm performance study is not relevant. The document refers to "animal and performance testing" which are standalone device evaluations, but not in the context of AI.

7. The Type of Ground Truth Used

The document implies that "appropriate testing" and "animal and performance testing" were conducted to demonstrate safety and effectiveness. However, it does not detail the specific "ground truth" used for these tests. For a device like a ligation clip, ground truth would typically come from direct observation of outcomes (e.g., successful hemostasis, complete closure, proper marking) by trained personnel during the "animal and performance testing."

8. The Sample Size for the Training Set

Not applicable. This question refers to the training of an AI algorithm. The Padlock Clip™ is a physical device, not an AI system, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, this pertains to AI algorithms.

Summary and Limitations:

The provided document is a 510(k) summary for a medical device (Padlock Clip™), not for an AI algorithm. Therefore, many of the questions regarding AI-specific studies (MRMC, standalone algorithm performance, training/test sets for AI, expert ground truth for AI) are not applicable.

For the physical device itself, the document states that "appropriate testing" and "animal and performance testing" were conducted, concluding that the device is "acceptable for its intended use" and shows "no new issues of safety or effectiveness." However, it does not provide specific details about:

The acceptance criteria (e.g., quantitative thresholds for success rates).
The exact protocols, sample sizes, or results of these "animal and performance testing."
The specific methods for establishing ground truth during these tests.

This level of detail is typically found in the full 510(k) submission or supporting technical documentation, which is not included in this public summary. The purpose of this summary is primarily to establish substantial equivalence to a predicate device (OVESCO Endoscopy AG OTSCTM).

Summary

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K120814
pg 1 of 2

SEP 6 2012

Section 3: 510(k) Summary (Per 21 CFR 807.92)

Establishment Information:

Aponos Medical Corp. is located at: Unit 7, RT 125 Kingston, NH 03848

The Company intends to register with FDA upon receipt of clearance of this 510(k) Notice, and prior to initiating distribution of any products. The manufacturing of the Padlock Clip™ device will be carried out by Aponos at their facility at the same location.

General Company Information:

17 Route 125, Bldg. A #7 Kingston, NH 03848 Phone: 603-347-8229 Fax: 978-945-6197

CTO

John Fee VP of Quality and Regulatory Affairs Phone: 603-702-0066 Email: tjfee@aol.com

Date Prepared

General Device Information:

Official Correspondent:

Product Name:

Common Name:

Classification Name:

Regulation Number:

Product Codes:

Predicate Device(s)

September 5, 2012

Aponos Medical Corp. Denis LaBombard

Padlock Clip™ (Padlock-G Clip)

Ligation clip

ligator, esophageal

21 CFR 876.440

MND and FHN. Class II device

OVESCO Endoscopy AG OTSCTM 'Over-The-Scope-Clipping System Set including the OTSCTM Reloader. 510k - K101428

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510(k) Number - K120814

Device Name: Aponos Medical, Padlock Clip™

Indications for Use:

The Padlock Clip is indicated for clip placement within the Gastro-intestinal (GI) tract for the purpose of:

Endoscopic marking of lesions. .
Hemostasis for .
- Mucosal/Sub mucosal defects o
- o Bleeding Ulcers
- Arteries <2mm o
- Polyps <1.5cm diameter O
- Diverticula in the Colon o
Closure of GI tract luminal perforations < 20mm that can be treated . conservatively.

Description of Device:

Compliance with Special Controls:

Aponos Medical is unaware of any performance standard regarding this type of device that has been promulgated by FDA.

Performance Standards:

Aponos Medical has conducted appropriate testing and has determined that the Padlock Clip ligation clip is acceptable for its intended use.

Section 9 includes completed Standard Data Reports (Form FDA 3654) for these standards, as well as those relevant to sterilization, referenced in this submission.

Technological Characteristics Summary:

The Padlock Clip™ system set is substantially equivalent to the predicates, as they have similar technological characteristics. The results of animal and performance testing show no new issues of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circle. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 25, 2015

Aponos Medical Corp. John Fee VP of Quality & Regulatory Affairs 16 Hillside Road Kingston, NH 03848

Re: K120814

Trade/Device Name: Aponos Medical, Padlock Clip™ Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL Dated (Date on orig SE ltr): August 20, 2012 Received (Date on orig SE ltr): August 21, 2012

Dear John Fee,

This letter corrects our substantially equivalent letter of September 6, 2012.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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Page 2 -

found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Joyce M. Whang -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4: Indications for Use Statement

510(k) Number - K120814

Device Name: Aponos Medical, Padlock Clip™

Indications for Use:

The Padlock Clip is indicated for clip placement within the Gastro-intestinal (GI) tract for the purpose of:

Endoscopic marking of lesions. .
Hemostasis for ●

Mucosal/Sub mucosal defects o
Bleeding Ulcers o
Arteries <2mm o
0 Polyps <1.5cm diameter
o Diverticula in the Colon

Closure of GI tract luminal perforations < 20mm that can be treated conservatively.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, andUrological Devices
510(k) Number	K120814

Regulation Number and Section

§ 876.4400 Hemorrhoidal ligator.

(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.